EP0729728A1 - Dispositif de prélèvement sanguin - Google Patents

Dispositif de prélèvement sanguin Download PDF

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Publication number
EP0729728A1
EP0729728A1 EP95890042A EP95890042A EP0729728A1 EP 0729728 A1 EP0729728 A1 EP 0729728A1 EP 95890042 A EP95890042 A EP 95890042A EP 95890042 A EP95890042 A EP 95890042A EP 0729728 A1 EP0729728 A1 EP 0729728A1
Authority
EP
European Patent Office
Prior art keywords
collection device
blood collection
handle part
needle
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP95890042A
Other languages
German (de)
English (en)
Inventor
Erich Ing. Kleinhappl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AVL Medical Instruments AG
Original Assignee
AVL Medical Instruments AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by AVL Medical Instruments AG filed Critical AVL Medical Instruments AG
Priority to EP95890042A priority Critical patent/EP0729728A1/fr
Priority to US08/592,801 priority patent/US5715833A/en
Priority to JP8032529A priority patent/JPH08308819A/ja
Publication of EP0729728A1 publication Critical patent/EP0729728A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device

Definitions

  • the invention relates to a blood sampling device, in particular for taking arterial blood samples, with a handle part, a needle adapter on which a puncture cannula can be plugged in, and a sample capillary connected to the puncture cannula, and a method for producing such a device.
  • a number of removal devices have become known, which essentially consist of a combination of plunger syringe and puncture cannula in sterile packaged form.
  • the syringes used have a dead space at the input part of the syringe, which can be filled with an additive that prevents blood clotting, for example with heparin.
  • a removal device which does not require a piston syringe is disclosed in AT-PS 363 169.
  • the blood collection device has an at least partially transparent sheath, the closed front wall of which is provided with a connection piece for receiving a puncture cannula.
  • This connector has an opening opening into the interior of the envelope, into which a glass capillary can be inserted.
  • the capillary serves as a sample container and is filled by arterial blood pressure.
  • the socket is provided with a protective cap covering the puncture cannula, which is removed before the blood is drawn.
  • In the rear end of the envelope there is a closure part, in which the rear end of the sample capillary is inserted.
  • the closure part together with the filled capillary can be removed from the sheath and, for example, attached to an analysis device.
  • the closure part can also accommodate two sample capillaries connected by a U-shaped channel.
  • the object of the present invention is to avoid the disadvantages mentioned and, in particular, to propose a blood collection device which is simple and robust and at the same time permits an inexpensive production process.
  • handle part and the sample capillary are made in one piece as a blow molded part and that the needle adapter is either molded in one piece or can be inserted as a separate component into an opening of the handle part opening into the sample capillary.
  • the blood sampling device is produced from a thermoplastic, tubular, body essentially in one piece as a blow molding, the outer contours being represented by a preferably two-part pressing tool and the lumens of the sample capillary and any other channels by blow molding.
  • the needle adapter is also molded in one piece, a small amount of reworking of the mating surfaces, which cannot be produced without burrs, will usually be necessary to attach the puncture cannula.
  • an integrally molded, vented reservoir connects to the end of the sample capillary facing away from the needle adapter and serves as a sample overflow.
  • a particularly easy-to-handle embodiment variant of the invention is characterized in that the reservoir adjoining the sample capillary is tubular or tubular and is integrated in a bead-shaped edge of the essentially plate-shaped handle part.
  • the blood sampling device called the microsampler, was designed for easy blood sampling directly from the patient.
  • the blood is drawn using a conventional, enclosed puncture cannula, which is unpacked and attached immediately before puncturing.
  • a puncture cannula has to be sterile, the blood collection device itself does not need to be sterilized under normal conditions of use.
  • the blood sample is pumped into the sampling device by the arterial blood pressure, the ventilation being carried out through a small hole in the bead-shaped edge of the handle part.
  • the blood collection device is designed as a disposable item, which is disposed of after use.
  • samples for blood gas analysis can be stored in the blood collection device for up to 30 minutes, for example.
  • Transparent material can also be used to visually check the filling level of the sample capillary.
  • Suitable materials are e.g. B. acrylonitrile-methyl-acrylate copolymers, PMMA, polycarbonate, polyethylene and polypropylene.
  • an integrally molded reservoir adjoins the end of the sample capillary facing away from the needle adapter, which has a deformable region at the touch of a finger for filling and emptying the sample capillary.
  • This embodiment variant has the advantage that a completely closed system can be implemented here without venting, and a pumping and suction effect in the sample channel can be achieved via the deformable area of the reservoir.
  • the grip part can have an integrally molded needle protector, which has a molded one, without making the blood collection device according to the invention significantly more expensive or increasing the assembly effort
  • Rotary hinge preferably a film hinge, is attached to the handle part, the shape of the needle protector being designed to securely hold the puncture cannula.
  • a particularly advantageous embodiment provides that a central web area is provided for the integral design of the needle protector, which is connected to the handle part on its circumference via molded, easily penetrable predetermined breaking points and on a flexible connecting piece via the film hinge.
  • the needle protector is thus automatically shaped without any further effort.
  • the required predetermined breaking points are formed by appropriate tool design.
  • the needle protector is opened by finger pressure and rotated over the puncture cannula.
  • the puncture cannula snaps into a molded groove of the needle protector, the twist of the needle breaking the film hinge of the protector and the needle and the protector being able to be disposed of.
  • the grip part of the blood collection device can additionally have a closure cap molded in one piece, which is attached to the grip part via a molded hinge, preferably a film hinge, the closure cap being designed by its shape for the secure closure of the needle adapter. Furthermore, a further web area can be provided for the integral design of the closure cap, the design of which corresponds to that of the needle protector. After removing the needle protector, the cap is pulled out by finger pressure and pressed onto the needle adapter. As a result, the sample capillary is tightly sealed on the inlet side, so that no blood sample can escape during transport.
  • a further development of the invention provides that further web areas are provided which have a surface which is suitable for the direct labeling of the blood collection device, preferably roughened, or which have a preferably smooth surface suitable for being affixed with labels or machine-readable codes.
  • a recessed grip for safe handling of the blood collection device is provided in the adapter-side section of the handle part by indenting the bead-shaped edge.
  • the pressure-deformable reservoir for sucking in and emptying the sample capillary can advantageously also be arranged in this area.
  • the inner surface of the blood collection device can be rinsed with a heparin solution. Heparin dissolved in distilled water is preferably used for this.
  • FIG. 1 shows a top view of the blood collection device according to the invention
  • FIG. 2 shows a side view
  • FIGS. 3 and 4 show sectional views along the lines III-III and IV-IV in FIG. 1 and FIGS. 5 and 6 an embodiment variant in a top and side view according to FIGS. 1 and 2.
  • the blood sampling device shown approximately in normal size in FIGS. 1 to 4 has a flat (see FIG. 2) flake-shaped handle part 1 in the form of a narrow rectangle with rounded edges, to which either a needle adapter 2 is integral at one end is integrally formed, or which has an opening 2 'into which a preformed needle adapter 2 can be inserted.
  • a conventional puncture cannula or removal needle 3 can be z.
  • B. a Luer lock All other parts of the blood collection device described below are in one piece, i. H. manufactured as a blow molding in one operation.
  • the handle part 1 of the removal device which is made of transparent plastic in the variant shown, then has, on the needle adapter 2, a sample cannula 4 which opens into a tubular or tubular reservoir 6 forming a bead-shaped edge 5 of the handle part 1.
  • a constriction 4 ′ can be formed at the confluence with the reservoir 6.
  • the blood sampling device is vented via a small bore 7 in the reservoir 6.
  • the sample capillary 4 and the tubular reservoir 6 are arranged such that a central, integrally molded web area 8 and further web areas 9, 10 etc. between the sample capillary 4 and Find reservoir 6 for receiving or shaping other integrated components of the blood collection device.
  • a needle protector 11 which is formed in one piece and which has predetermined breaking points 12 with respect to the web area 8, so that it can be folded out of the handle part 1 with slight finger pressure. Such a position is indicated by dashed lines in Fig. 2.
  • the needle protector 11 can be folded over the attached puncture cannula 3 via a molded flexible connecting piece 13, which is fastened to the handle part 1 or at the web area with a film hinge, so that a flange 15 of the luer lock of the puncture cannula 3 is inserted into a groove 16 of the needle protector 11 engages and fixes it.
  • the needle protector 11 is then together with the puncture cannula 3 rotated about the axis of the puncture cannula in such a way that the film hinge 14 breaks and the needle together with the protector can be removed from the blood collection device and safely disposed of.
  • an integrally formed closure cap 17 can be folded out of a further web area 9 of the handle part, predetermined breaking points 12 and a flexible connecting piece 18 also being provided here, which is rotatably connected to the handle part 1 or the web area 9 via a further film hinge 14 .
  • the folded-out closure cap 17 is shown in broken lines in FIG. 2. With the closure cap 17, the needle adapter 2 is closed in a gastight and liquid-tight manner after sampling and after removal of the puncture cannula 3.
  • Further web areas 10 within the bead-shaped edge 5 can have a smooth surface 19, which is suitable for being affixed with labels or machine-readable codes.
  • the rear surface 20 of the area 10 or other web areas can be roughened, for direct labeling e.g. have suitable surfaces using a fiber pen.
  • a recess 22 for a safe handling of the blood collection device can be provided by an indentation 21 in the bead-shaped edge 5.
  • the volume of the sample capillary 4 is defined by the blow mold, the material wall thickness and the length of the capillary.
  • a typical volume, e.g. B. for the analysis of blood gas and electrolyte readings for modern analyzers is approx. 200 ⁇ l.
  • the material wall thickness for the sample capillary 4, the reservoir 6 and the web areas 8 to 10 is approximately 1 to 2 mm, depending on the starting material used.
  • the length and the diameter of the sample capillary can be selected so that a sample volume between 100 and 500 ⁇ l results.
  • the section according to FIG. 3 in the area of the needle protector 11 shows web areas 8 arranged symmetrically to the reservoir 6 and to the sample capillary 4.
  • the web areas 9 are molded on one side on the sample capillary 4 and the tubular reservoir 6.
  • FIGS. 1 to 6 The arrangement of the individual components of a blood collection device shown in FIGS. 1 to 6 is only to be understood as an exemplary embodiment. Of course, other arrangements also fall under the inventive basic idea, as long as the essential components of a blood collection device, such as a sample capillary and integrated handle part, as well as, if necessary, the needle adapter and a reservoir can be produced in one piece as a blow molded part.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
EP95890042A 1995-02-28 1995-02-28 Dispositif de prélèvement sanguin Withdrawn EP0729728A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP95890042A EP0729728A1 (fr) 1995-02-28 1995-02-28 Dispositif de prélèvement sanguin
US08/592,801 US5715833A (en) 1995-02-28 1996-01-26 Blood sampler
JP8032529A JPH08308819A (ja) 1995-02-28 1996-02-21 採血装置とその製造方法

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP95890042A EP0729728A1 (fr) 1995-02-28 1995-02-28 Dispositif de prélèvement sanguin

Publications (1)

Publication Number Publication Date
EP0729728A1 true EP0729728A1 (fr) 1996-09-04

Family

ID=8222176

Family Applications (1)

Application Number Title Priority Date Filing Date
EP95890042A Withdrawn EP0729728A1 (fr) 1995-02-28 1995-02-28 Dispositif de prélèvement sanguin

Country Status (3)

Country Link
US (1) US5715833A (fr)
EP (1) EP0729728A1 (fr)
JP (1) JPH08308819A (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69939598D1 (de) * 1999-01-04 2008-10-30 Terumo Corp Landzettenanordnung zur entnahme und zum nachweis von körperflüssigkeiten
US6612111B1 (en) * 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples
US8166381B2 (en) * 2000-12-20 2012-04-24 Heart Imaging Technologies, Llc Medical image management system
US6934698B2 (en) * 2000-12-20 2005-08-23 Heart Imaging Technologies Llc Medical image management system
US20030039587A1 (en) * 2001-08-22 2003-02-27 Volker Niermann Transfer device
US10398361B2 (en) * 2012-01-10 2019-09-03 Becton, Dickinson And Company Low cost blood collection set using blister package
US11312143B2 (en) * 2017-07-17 2022-04-26 Hewlett-Packard Development Company, L.P. Fluid interface device with sliding needle

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3640388A (en) * 1970-08-20 1972-02-08 Damon Corp Dialyzing liquid-collecting container
US4132225A (en) * 1976-11-18 1979-01-02 Hynson, Westcott & Dunning, Inc. Micro blood collector
US4215700A (en) * 1978-08-25 1980-08-05 Sherwood Medical Industries Inc. Blood collection device
US4342184A (en) * 1972-09-29 1982-08-03 Eck William F Van Method of manufacture of hypodermic syringe
EP0400216A1 (fr) * 1989-06-01 1990-12-05 Program For Appropriate Technology In Health Seringue à jeter pour l'usage unique
US5154285A (en) * 1990-08-01 1992-10-13 Smiths Industries Medical Systems, Inc. Needle assembly holder with rotatable safety sheath member

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH618334A5 (fr) * 1977-09-08 1980-07-31 Avl Ag
US5033476A (en) * 1986-12-11 1991-07-23 Terumo Kabushiki Kaisha Blood collecting tube
US5562639A (en) * 1987-07-31 1996-10-08 Lynn; Lawrence A. Vented fluid collection system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3640388A (en) * 1970-08-20 1972-02-08 Damon Corp Dialyzing liquid-collecting container
US4342184A (en) * 1972-09-29 1982-08-03 Eck William F Van Method of manufacture of hypodermic syringe
US4132225A (en) * 1976-11-18 1979-01-02 Hynson, Westcott & Dunning, Inc. Micro blood collector
US4215700A (en) * 1978-08-25 1980-08-05 Sherwood Medical Industries Inc. Blood collection device
EP0400216A1 (fr) * 1989-06-01 1990-12-05 Program For Appropriate Technology In Health Seringue à jeter pour l'usage unique
US5154285A (en) * 1990-08-01 1992-10-13 Smiths Industries Medical Systems, Inc. Needle assembly holder with rotatable safety sheath member

Also Published As

Publication number Publication date
US5715833A (en) 1998-02-10
JPH08308819A (ja) 1996-11-26

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